Copper T 380A intra-uterine contraceptive device (IUCD) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 manufacturer #13850 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2006-01-18
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Press release
  • 원인
    Dh notified of intra-uterine contraceptive device cases 18 january 2006 (wednesday) in response to media enquiries, a spokesman for the department of health confirmed that the department has received notification from family planning association of hong kong (fpahk) that it was calling back all clients inserted with copper t 380a intra-uterine contraceptive device (iucd) for removal with or without replacement with another type of iucd. the association observed two cases of partially broken copper t 380a iucd of batch number 60401 and decided to call back all patients concerned as precautionary measure because broken iucd could lead to reduced contraceptive efficacy. the spokesman said that dh has alerted hospital authority, private hospitals, professional associations and medical practitioners of the incident of breakage of the batch of iucds . so far, no serious injuries related to breakage of these iucds have been reported locally or overseas. the spokesman said that dh did not use copper t 380a iucd of this batch. he called on women with iucds inserted should consult their doctors for advice. “if they suspect that they are pregnant or have symptoms of abnormal or severe abdominal pain, excessive menstrual flow or abnormal vaginal discharge, they should consult their doctors immediately,” he said.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: DH notified of intra-uterine contraceptive device cases
  • Manufacturer

Manufacturer